In the study, a total of 170 patients were randomized to placebo,
apremilast 40 mg BID or apremilast 30 mg BID. The primary endpoint of
the study was Total Mayo Score (TMS) clinical remission at week 12 for
the 40 mg BID arm. At week 12, TMS clinical remission was achieved by
21.8 percent of patients in the apremilast 40 mg BID arm (n=55) versus
13.8 percent in the placebo group (n=58; P=non-significant (NS)). In the
apremilast 30 mg BID arm, 31.6 percent of patients (n=57) achieved
clinical remission as measured by TMS at week 12 versus 13.8 percent in
the placebo group (n=58; nominally significant, P<0.05).

“The achievement of clinical remission, which requires endoscopic
improvement of the mucosa, is a meaningful goal in the treatment of
ulcerative colitis,” said presenting author Silvio Danese, M.D., Ph.D.,
Head of the Inflammatory Bowel Disease Clinical and Research Center,
Humanitas Research Hospital. “These findings suggest apremilast, which
improved the likelihood of achieving remission in this 12-week study,
merits further study in a larger trial.”

Apremilast is not approved for the treatment of ulcerative colitis in
any country. In January 2018, the U.S. Food and Drug Administration
designated apremilast an Orphan Drug for the potential treatment of
pediatric patients with ulcerative colitis.

About Ulcerative Colitis

Ulcerative colitis is a chronic, relapsing condition triggered by an
abnormal, prolonged immune response that creates long-lasting
inflammation and ulcers (sores) in the mucosa (lining) of the large
intestine (colon). Symptoms usually develop over time, rather than
suddenly. The disease can be debilitating and can sometimes lead to
life-threatening complications. Ulcerative colitis is the most common
form of inflammatory bowel disease worldwide. About one in every 198
people in Europe and one in every 402 people in North America have
ulcerative colitis. In 2004, 2.1 million prescriptions were written to
treat ulcerative colitis, and 716,000 ambulatory care visits were
related to the disease. In 2010, there were 107,000 hospitalizations due
to ulcerative colitis.

About OTEZLA®

OTEZLA® (apremilast) 30 mg tablets is an oral small-molecule
inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine
monophosphate (cAMP). PDE4 inhibition results in increased intracellular
cAMP levels, which is thought to indirectly modulate the production of
inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts
its therapeutic action in patients is not well defined.

U.S. PRESCRIBING INFORMATION

INDICATIONS

OTEZLA® (apremilast) is indicated for the treatment of
patients with moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy.

OTEZLA is indicated for the treatment of adult patients with active
psoriatic arthritis.

IMPORTANT SAFETY INFORMATION

Contraindications

OTEZLA® (apremilast) is contraindicated in patients with a
known hypersensitivity to apremilast or to any of the excipients in the
formulation

Warnings and Precautions

Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea, and
vomiting were associated with the use of OTEZLA. Most events occurred
within the first few weeks of treatment. In some cases, patients were
hospitalized. Patients 65 years of age or older and patients taking
medications that can lead to volume depletion or hypotension may be at a
higher risk of complications from severe diarrhea, nausea, or vomiting.
Monitor patients who are more susceptible to complications of diarrhea
or vomiting; advise patients to contact their healthcare provider.
Consider OTEZLA dose reduction or suspension if patients develop severe
diarrhea, nausea, or vomiting

Depression: Carefully weigh the risks and benefits of treatment with
OTEZLA for patients with a history of depression and/or suicidal
thoughts/behavior, or in patients who develop such symptoms while on
OTEZLA. Patients, caregivers, and families should be advised of the need
to be alert for the emergence or worsening of depression, suicidal
thoughts or other mood changes, and they should contact their healthcare
provider if such changes occur

Psoriasis: Treatment with OTEZLA is
associated with an increase in depression. During clinical trials, 1.3%
(12/920) of patients reported depression compared to 0.4% (2/506) on
placebo; Depression was reported as serious in 0.1% (1/1308) of patients
exposed to OTEZLA, compared to none in placebo-treated patients (0/506).
Suicidal behavior was observed in 0.1% (1/1308) of patients on OTEZLA,
compared to 0.2% (1/506) on placebo. One patient treated with OTEZLA
attempted suicide; one patient on placebo committed suicide

Psoriatic Arthritis: Treatment with OTEZLA
is associated with an increase in depression. During clinical trials,
1.0% (10/998) reported depression or depressed mood compared to 0.8%
(4/495) treated with placebo. Suicidal ideation and behavior was
observed in 0.2% (3/1441) of patients on OTEZLA, compared to none in
placebo treated patients. Depression was reported as serious in 0.2%
(3/1441) of patients exposed to OTEZLA, compared to none in placebo
treated patients (0/495). Two patients who received placebo committed
suicide compared to none on OTEZLA

Pregnancy and Nursing Mothers: OTEZLA is Pregnancy Category C; it has
not been studied in pregnant women. Use during pregnancy only if the
potential benefit justifies the potential risk to the fetus. It is not
known whether apremilast or its metabolites are present in human milk.
Caution should be exercised when OTEZLA is administered to a nursing
woman

Renal Impairment: OTEZLA dosage should be reduced in patients with
severe renal impairment (creatinine clearance less than 30 mL/min); for
details, see Dosage and Administration, Section 2, in the Full
Prescribing Information

Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global pharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through
next‐generation solutions in protein homeostasis, immuno‐oncology,
epigenetics, immunology and neuro‐inflammation. For more information,
please visit www.celgene.com.
Follow Celgene on Social Media: @Celgene,
Pinterest,
LinkedIn,
Facebook
and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are
generally statements that are not historical facts. Forward-looking
statements can be identified by the words “expects,” “anticipates,”
“believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and
similar expressions. Forward-looking statements are based on
management’s current plans, estimates, assumptions and projections, and
speak only as of the date they are made. We undertake no obligation to
update any forward-looking statement in light of new information or
future events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which are
difficult to predict and are generally beyond our control. Actual
results or outcomes may differ materially from those implied by the
forward-looking statements as a result of the impact of a number of
factors, many of which are discussed in more detail in our Annual Report
on Form 10-K and our other reports filed with the U.S. Securities and
Exchange Commission.

Hyperlinks are provided as a convenience and for informational
purposes only. Celgene bears no responsibility for the security or
content of external websites.